# K153255: Aero Chrome* Breathable Performance Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Halyard Health, Inc.
- Decided: Apr 13, 2016 after 155 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K981393 (1998). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140539: Aero Blue Performance Surgical Gown, Kimberly-Clark Corporation (2014) Summary page 6.

## Most influential descendants
- K200522: AERO CHROME* Breathable Performance Surgical Gowns (2020), 2 descendants of its own
- K260725: BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (2026), 0 descendants of its own
- K210688: AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown (2021), 0 descendants of its own
- K162930: Aero Chrome* Select Breathable Performance Surgical Gowns (2017), 0 descendants of its own

## Indications for use
The Aero Chrome* Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications. The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization

Source page: https://510kreport.com/device/K153255
Methodology: https://510kreport.com/methodology